Overview

This trial is active, not recruiting.

Condition urinary incontinence
Treatment biofeedback; functional electrical stimulation; pelvic floor muscle training exercises
Sponsor Azienda Ospedaliero Universitaria Maggiore della Carita
Start date February 2007
End date November 2009
Trial size 110 participants
Trial identifier NCT00982098, NO08974

Summary

Urinary incontinence is a frequent complication after radical prostatectomy. Rehabilitative treatments are frequently utilized to reduce incontinence. However, their efficacy has not been completely investigated. In this study the investigators will compare the effect of an early rehabilitation programme (instruction of the patient, pelvic floor muscle training, electrical stimulation and biofeedback) versus instruction of the patient only.

The investigators hypothesis is that early rehabilitation programme is more effective than patient's instruction alone in preventing urinary incontinence after radical prostatectomy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Before surgery: 15 minutes pelvic floor muscle training and 15 minutes biofeedback, for 4 sessions. After surgery: physical therapist's assisted pelvic floor muscle biofeedback (15 min/day for 10 days), followed by patient's instruction for pelvic floor muscle training and home based exercised pelvic floor muscle for 10 days. Then pelvic floor muscle biofeedback (15 min/day for 10 days) and functional electrical stimulation of pelvic floor (30 min/day for 10 days). Patients will be instructed to carry on exercises at home for the following 11 months.
biofeedback; functional electrical stimulation; pelvic floor muscle training exercises
After surgery: physical therapist's assisted pelvic floor muscle biofeedback (15 min/day for 10 days), followed by patient's instruction for pelvic floor muscle training and home based exercised pelvic floor muscle for 10 days. Then pelvic floor muscle biofeedback (15 min/day for 10 days) and functional electrical stimulation of pelvic floor (30 min/day for 10 days).
(No Intervention)
Before surgery: 15 minutes pelvic floor muscle training and 15 minutes biofeedback, for 4 sessions. After surgery: Patients will be instructed to carry on pelvic floor exercises at home for the year after prostatectomy.

Primary Outcomes

Measure
Complete continence (PAD test 24 hours <10 cc)
time frame: 12 months

Secondary Outcomes

Measure
PAD test 24 hours
time frame: 12 months

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - men who will undergo radical prostatectomy for prostatic cancer Exclusion Criteria: - previous urinary and/or faecal incontinence - neurologic bladder - previous pelvic surgery

Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by Azienda Ospedaliero Universitaria Maggiore della Carita.